Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00416780|
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : May 30, 2013
RATIONALE: Meeting together with other breast cancer patients to receive psychosocial support and to learn to reduce stress may help patients cope with their diagnosis, have a better quality of life, and live more comfortably.
PURPOSE: This randomized clinical trial is studying how well psychosocial support works in treating women with recurrent breast cancer or stage I, stage II, or stage IV breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Psychosocial Effects of Cancer and Its Treatment||Other: counseling intervention Other: educational intervention Procedure: psychosocial assessment and care||Not Applicable|
- Evaluate theoretically derived psychosocial interventions (peer discussion support vs education and stress management vs usual-care control) targeted to enhance adjustment and functional status and lower morbidity among women diagnosed with and treated for recurrent or stage I, II, or IV breast cancer.
- Evaluate the psychological, behavioral, and biological pathways and their effects in patients treated with these interventions.
- Evaluate the efficacy of these intervention in these patients.
- Evaluate the nature and extent of coping strategies in these patients.
- Evaluate the differences in patients treated with these intervention vs those patients electing not to be treated with these interventions.
OUTLINE: This is a randomized study. Patients are stratified according to disease stage (early vs late). Patients with early-stage disease are randomized to 1 of 3 intervention arms. Patients with late-stage disease are randomized to 1 of 2 intervention arms (II or III).
- Arm I (education and stress management): Patients undergo a 1-hour group (6-10 patients per group) education session once a week for 8 weeks focusing on exchange of factual information between a facilitator and patients. The session includes a 45-minute lecture, discussing risks, diagnosis, and treatment of cancer; side effects from treatment; nutrition during treatment; and follow-up care, followed by a question/answer period and instruction in progressive relaxation techniques. Patients then receive 3 monthly phone calls from a project staff member to answer questions about cancer, treatment, and follow-up care and to discuss the relaxation exercises.
- Arm II (peer discussion): Patients undergo a 1-hour group (6-10 patients per group) peer support session once a week for 8 weeks focusing on the provision of emotional support among patients and the maintenance of purpose in life. The session emphasizes on the sharing of experiences, the development of a common bond, and the promotion of altruism to similar others. Patients then are given an opportunity to attend 3 monthly additional meetings to share critical experiences and problems they have experienced in the past month.
- Arm III (control): Patients receive usual care and are not asked to attend any meetings.
All patients undergo a 2-hour baseline interview, a 1.5-hour post intervention interview, and a 1.5-hour final interview 8 months after randomization.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Psychobiological Pathways: Breast Cancer Interventions|
|Actual Study Completion Date :||March 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416780
|Study Chair:||Michael Scheier, PhD||Pittsburgh Mind-Body Center at Carnegie Mellon University|